1. Field of the Invention
The present invention relates to suturing devices. Specifically, the present invention relates to suturing devices and methods for suturing biological tissue that may not directly accessible to the physician.
2. Description of the Related Art
Physicians frequently use sutures to close cuts, punctures, incisions and other openings in various biological tissue, such as blood vessels, of the human body.
In an arterial catheterization procedure, a relatively small percutaneous incision is made in the femoral or other artery. A catheter is inserted through the incision and directed along an arterial path to a target area, such as the heart, to perform one or more procedures, such as an angioplasty or angiogram. These procedures are designed to be relatively quick xe2x80x98outpatientxe2x80x99 procedures.
Upon completion of the catheterization procedure, the physician typically creates a xe2x80x98thrombus patchxe2x80x99 by applying direct pressure to the patient""s thigh to make the blood around the incision clot. Because the femoral artery must not be completely blocked (occluded) by the applied pressure, the physician commonly applies direct pressure by hand for the first twenty minutes after the procedure. During this time, the physician can feel the pulse to assure the artery is not occluded. Afterwards, the physician usually turns the procedure over to an assistant who applies direct pressure using sandbags, clamps or other devices. A significant problem with this approach is that it is frequently necessary to apply the pressure for an extended period of time, such as twenty-four hours or longer.
Another problem with the thrombus patch method is that the high blood pressure in the artery can cause the thrombus patch to rupture or burst while direct pressure is being applied to the thigh or after direct pressure is removed. This requires the whole process to be restarted. If the patch ruptures and is not restored, the patient may bleed to death. Because thrombus patches frequently burst, the patient frequently must remain in the hospital or catheterization lab overnight for observation. Thus, these xe2x80x98out-patientxe2x80x99 procedures become xe2x80x98in-patientxe2x80x99 procedures, simply because a thrombus patch it is difficult to create. Staying in the hospital increases patient discomfort and hospital expenses, which are often disproportionate to the actual medical procedure performed.
Furthermore, if a thrombus patch cannot be formed, the physician may need to anesthetize the patient, occlude blood flow to the artery, make a large incision in the thigh to allow conventional suturing with a needle, suture the artery with conventional means, restore blood flow to the artery, and suture the incision in the thigh. This results in additional discomfort and expenses for the patient.
While the above problems could potentially be avoided by suturing the blood vessel immediately following the catheterization procedure, the size and location of the artery make suturing difficult. Specifically, the opening in the thigh is typically too small and too deep to provide enough working space for suturing the artery using conventional methods. Thus, in order to suture the vessel according to conventional methods, the opening in the thigh would have to be significantly enlarged, potentially exposing the patient to additional pain, scarring, and health risks.
The present invention addresses the above problems by providing a suturing device and method for suturing biological tissue, such as, for example, an organ or blood vessel. The device is particularly well suited to suture an opening made in an artery, such as the femoral artery, following a catheterization procedure. The device eliminates the need to apply pressure to a patient""s thigh for an extended period of time, and eliminates many of the complications and costs associated with the creation of a thrombus patch.
One aspect of the invention relates to a suturing device comprising an elongate body and first and second arms. Each of said arms has a suture mounting portion which mounts an end portion of a suture. The arms are mounted on the elongate body such that said suture mounting portions are movable away from said body to a first position and towards said body to a second position. The suturing device further comprises first and second needles, each of said needles having a distal end. Each of said needles is mounted such that the distal end of the needle is movable (i) in a proximal to distal direction from a position adjacent said elongate body to a position spaced outwardly from said body, and (ii) towards the suture mounting portion of one of the arms when in said first position, wherein the respective distal ends of the first and second needles engage respective end portions of said suture. The suturing apparatus further comprises an actuator which drives the needles in said proximal to distal direction such that the engagement of the respective end portions of the suture is non-simultaneous.
Another aspect of the invention relates to a suturing apparatus comprising an elongate body and first and second arms. Each of said arms has a suture mounting portion which mounts an end portion of a suture, and each of said arms is operably connected to the elongate body such that said suture mounting portions are movable away from said body to a first position and towards said body to a second position. The suturing apparatus further comprises first and second needles, each of said needles having a distal end. Each of said needles is mounted such that the distal end of the needle is movable (i) in a proximal to distal direction from a position adjacent said elongate body to a position spaced outwardly from said body, and (ii) towards the suture mounting portion of one of the arms when in said first position. The suturing apparatus further comprises an actuator comprising first and second needle drivers connected to drive the first and second needles, respectively, in said proximal to distal direction. Said needle drivers are independently actuable such that the first needle is movable independent of the second needle.
Another aspect of the present invention relates to a device for suturing biological tissue. The device comprises an elongated body and an arm operably connected to the elongated body to move to an extended position away from the elongated body and to a retracted position toward the elongated body. The arm has a mounting portion which mounts a portion of a suture, and has a tissue contacting surface which faces proximally when the arm is in the extended position. The tissue contacting surface has a projecting portion configured to provide intimate contact with said tissue and to thereby inhibit lateral movement of said arm when said tissue contacting surface is pressed against tissue. The device further comprises a needle having a distal end which is movable distally from a position adjacent the elongated body towards said mounting portion of said arm when the arm is in the extended position, such that said distal end engages said portion of the suture mounted by said mounting portion.
Another aspect of the present invention relates to a suturing apparatus comprising an elongated body. The suturing apparatus further comprises an arm operably connected to the elongated body and movable relative to the elongated body to an extended position away from the elongated body and to a retracted position towards the elongated body. The arm has a mounting portion which mounts a portion of a suture. The suturing apparatus further comprises a needle movable relative to the elongated body. The needle has a distal end movable from a position adjacent the elongated body towards the mounting portion of the arm when the arm is in the extended position, such that the distal end engages the portion of the suture mounted by the mounting portion of the arm. The suturing apparatus further comprises a patch which is tethered by the suture.
Another aspect of the present invention relates to a method of suturing. The method comprises providing an elongate body having first and second arms which mount first and second portions, respectively, of a suture. The method further comprises engaging the first and second portions of the suture with first and second needles, respectively, by driving the first and second needles towards the first and second arms, respectively, in a proximal to distal direction. The engaging comprises engaging the first portion of suture with the first needle prior to engaging the second portion of the suture with the second needle.
Another aspect of the present invention relates to a method of occluding a septal defect. The method comprises inserting a distal end portion of an elongated body into an opening in a living being. The method further comprises positioning the distal end portion in a first location adjacent a first tissue portion in proximity to the septal defect. The method further comprises deploying a first needle within the elongated body so as to draw a first end of a suture through the first tissue portion. The method further comprises moving the distal end portion to a second location displaced from the first location and positioning the distal end portion adjacent a second tissue portion in proximity to the septal defect. The method further comprises deploying a second needle within the elongated body so as to draw a second end of the suture through the second tissue portion. The method further comprises using the suture to secure a patch across the septal defect.
Another aspect of the present invention relates to a method of suturing. The method comprises inserting a distal end portion of an elongated body into an opening in a living being. The method further comprises positioning the distal end portion in a first location adjacent a first tissue portion. The method further comprises deploying a first needle within the elongated body so as to draw a first end of a suture through the first tissue portion. The method further comprises moving the distal end portion to a second location displaced from the first location and positioning the distal end portion adjacent a second tissue portion. The method further comprises deploying a second needle within the elongated body so as to draw a second end of the suture through the second tissue portion. The method further comprises using the suture to secure a patch to the first and second tissue portions.
Another aspect of the present invention relates to a method of suspending a biological structure. The method comprises positioning a distal portion of an elongated body adjacent the biological structure to be suspended. The method further comprises positioning a first arm operably connected to the elongated body on one side of the biological structure, the first arm releasably holding a first end portion of a suture. The method further comprises extending a first needle toward the first end portion of the suture in the first arm. The first needle moves on an opposite side of the biological structure such that when the first needle engages the first end portion of the suture, the biological structure is encircled by the first arm, the first needle, and the elongated body. The method further comprises positioning a second arm operably connected to the elongated body adjacent a tissue portion. The second arm releasably holds a second end portion of the suture. The method further comprises extending a second needle through the tissue portion to engage the second end portion of the suture in the second arm. The method further comprises drawing the first end portion and second end portion of the suture toward the elongated body. The method further comprises tying the first end portion and second end portion of the suture to suspend the biological structure to the tissue portion.
Another aspect of the present invention relates to a method of placing a suture around the exterior of a biological structure. The method comprises advancing an elongate suturing device having an elongate body distally towards the biological structure. The method further comprises positioning a first suture portion mounted on the elongate device so that the first suture portion is proximate the biological structure. The method further comprises advancing a suture retrieving member of the elongate device past the biological structure without piercing the biological structure. Advancing the suture retrieving member comprises moving the suture retrieving member with the biological structure between the suture retrieving member and the elongate body. Advancing the suture retrieving member further comprises coupling the suture retrieving member to the first suture portion. The method further comprises drawing the first suture portion away from the biological structure by moving the suture retrieving member in a direction away from the biological structure. The method further comprises drawing a second suture portion away from the biological structure by moving at least a portion of the elongate device from the biological structure, whereby the suture extends in a loop around the biological structure.